Case 1:14-cv-01453-LPS Document 49 Filed 11/30/15 Page 1 of 23 PageID #: 1730
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`MEDA PHARMACEUTICALS INC. and
`CIPLA LTD.,
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`C.A. No. 14-1453-LPS
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` Plaintiffs,
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`v.
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`APOTEX INC. and APOTEX CORP.,
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` Defendants.
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`PLAINTIFFS MEDA AND CIPLA’S
`OPENING CLAIM CONSTRUCTION BRIEF
`
`Steven J. Balick (#2114)
`John G. Day (#2403)
`Andrew C. Mayo (#5207)
`ASHBY & GEDDES
`500 Delaware Ave., 8th Floor
`P.O. Box 1150
`Wilmington, DE 19899
`(302) 654-1888
`sbalick@ashby-geddes.com
`jday@ashby-geddes.com
`amayo@ashby-geddes.com
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`Attorneys for Plaintiffs
`Meda Pharmaceuticals Inc. and Cipla Ltd.
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`Of Counsel:
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`H. Keeto Sabharwal
`Dennies Varughese
`Uma N. Everett
`Rami Bardenstein
`Dallin G. Glenn
`Joshua I. Miller
`Josephine J. Kim
`STERNE, KESSLER, GOLDSTEIN &
` FOX P.L.L.C.
`1100 New York Ave., N.W., Suite 800
`Washington, DC 20005-3934
`(202) 371-2600
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`Dated: November 23, 2015
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`Case 1:14-cv-01453-LPS Document 49 Filed 11/30/15 Page 2 of 23 PageID #: 1731
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`TABLE OF CONTENTS
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`INTRODUCTION .......................................................................................................................... 1 
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`I. 
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`II. 
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`NATURE AND STAGE OF THE PROCEEDINGS ......................................................... 2 
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`SUMMARY OF THE ARGUMENTS ............................................................................... 2 
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`III. 
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`STATEMENT OF FACTS ................................................................................................. 4 
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`A. 
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`B. 
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`C. 
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`The Disclosure and Claims of the Patents-in-Suit .................................................. 4 
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`The Prosecution History of the Patents-in-Suit ...................................................... 5 
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`The Relevant Person of Ordinary Skill in the Art ................................................... 6 
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`ARGUMENT .................................................................................................................................. 7 
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`I. 
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`II. 
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`APPLICABLE LAW OF CLAIM CONSTRUCTION ...................................................... 7 
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`PLAINTIFFS’ CONSTRUCTION OF “CONDITION(S)” IS CORRECT ....................... 8 
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`A. 
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`B. 
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`A POSA Reading the Patents Would Understand “Condition(s)”
`to Mean “condition(s) resulting in or causing allergic reaction(s)” ........................ 9 
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`Apotex’s Construction Undermines the Teachings of the Patents
`and Their Prosecution Histories, Which Are Explicitly Directed
` to Allergic Reactions............................................................................................ 11 
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`III. 
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`PLAINTIFFS’ CONSTRUCTION OF “ADMINISTRATION”
`IS CORRECT. .................................................................................................................. 12 
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`A. 
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`B. 
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`“Administration” Needs No Construction Because It is Used
`Throughout the Specification and Claims by Its Plain and
`Ordinary Meaning ................................................................................................. 13 
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`Apotex Contradicts the Prosecution History Because the Patentees
`Disavowed Claim Scope that Apotex Now Seeks to Reinsert .............................. 14 
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`CONCLUSION ............................................................................................................................. 18 
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`Case 1:14-cv-01453-LPS Document 49 Filed 11/30/15 Page 3 of 23 PageID #: 1732
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`TABLE OF AUTHORITIES
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` Page(s)
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`Cases
`
`Acumed LLC v. Stryker Corp.
`483 F.3d 800 (Fed. Cir. 2007)..................................................................................................... 8
`
`
`Agfa Corp. v. Creo Products, Inc.
`451 F.3d 1366 (Fed. Cir. 2006)................................................................................................. 14
`
`
`AstraZeneca AB v. Hanmi USA, Inc.
`554 Fed. App'x 912 (Fed. Cir. 2013) .......................................................................................... 9
`
`
`Callicrate v. Wadsworth Mfg., Inc.
`427 F.3d 1361 (Fed. Cir. 2005)................................................................................................... 9
`
`
`Chimie v. PPG Industries, Inc.
`402 F.3d 1371 (Fed. Cir. 2005)............................................................................................. 8, 15
`
`
`K-2 Corp. v. Salomon S.A.
`191 F.3d 1356 (Fed. Cir. 1999)................................................................................................. 12
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`Laryngeal Mask Co. Ltd. v. Ambu A/S
`618 F.3d 1367 (Fed. Cir. 2010)................................................................... 2, 7, 9, 12, 13, 16, 18
`
`
`Markman v. Westview Instruments, Inc.
`52 F.3d 967 (Fed. Cir. 1995)................................................................................................. 7, 12
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`Omega Eng’g, Inc. v. Raytek Corp.
`334 F.3d 1314 (Fed. Cir. 2003)................................................................................................. 16
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`Phillips v. AWH Corp.
`415 F.3d 1303 (Fed. Cir. 2005)................................................................................... 3, 7, 10, 14
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`Regents of Univ. of Minn. v. AGA Med. Corp.
`717 F.3d 929 (Fed. Cir. 2013)................................................................................................... 10
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`Retractable Techs., Inc. v. Beckton, Dickinson & Co.
`653 F.3d 1296 (Fed. Cir. 2011)................................................................................................... 3
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`Rheox, Inc. v. Entact, Inc.
`276 F.3d 1319 (Fed. Cir. 2002)................................................................................................. 17
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`Superguide Corp. v. DirecTV Enterprises, Inc.
`358 F.3d 870 (Fed. Cir. 2004)..................................................................................................... 7
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`Case 1:14-cv-01453-LPS Document 49 Filed 11/30/15 Page 4 of 23 PageID #: 1733
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`Tex. Instruments Inc. v. U.S. Int’l Trade Comm’n
`988 F.2d 1165 (Fed. Cir. 1993)................................................................................................... 7
`
`
`Thorner v. Sony Computer Entertainment America LLC
`669 F.3d 1362 (Fed. Cir. 2012)........................................................................................... 13, 18
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`Trading Techs. Int’l, Inc. v. eSpeed, Inc.
`595 F.3d 1340 (Fed. Cir. 2010)................................................................................................... 8
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`
`Verizon Servs. Corp. v. Vonage Holdings Corp.
`503 F.3d 1295 (Fed. Cir. 2007)............................................................................................... 7, 9
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`World Class Technology Corp. v. Ormco Corp.
`769 F.3d 1120 (Fed. Cir. 2014)................................................................................................. 11
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`Case 1:14-cv-01453-LPS Document 49 Filed 11/30/15 Page 5 of 23 PageID #: 1734
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`INTRODUCTION
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`Plaintiffs Meda Pharmaceuticals Inc. and Cipla Ltd. (together, “Plaintiffs”) submit this
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`Opening Claim Construction Brief to address disputed patent claim terms in this patent
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`infringement action. There are two patents in suit: U.S. Patent Nos. 8,163,723 (“the ’723 patent”)
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`and 8,168,620 (“the ’620 patent”). They are directed to a single-dosage formulation for the
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`simultaneous administration of two active pharmaceutical ingredients: azelastine and fluticasone.
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`The commercial embodiments of the patents—Meda’s Dymista® (which is marketed in the U.S.
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`and in numerous other countries) and Cipla’s Duonase (which is marketed in India) are
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`groundbreaking, highly-successful nasal spray products indicated for the treatment of allergic
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`rhinitis.
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`The parties dispute the meaning of only two claim terms in this action: condition(s) and
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`administration. As discussed below, Plaintiffs’ construction follows the plain and ordinary
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`meaning of each term, as read in the context of the patents and their prosecution histories.
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`Defendants, Apotex Inc. and Apotex Corp. (together, “Apotex”), on the other hand, propose
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`constructions that ignore both the plain meaning of the terms and the clear context of the patents.
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`Plaintiffs maintain that “condition” means a disease-condition “resulting in or causing
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`allergic reactions,” consistent with the subject matter of the patents. Apotex wants this Court to
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`construe “condition” to mean any “disease or illness” (e.g., cancer), disregarding the patents’
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`intrinsic record and teachings. Similarly, Plaintiffs maintain that “administration” is clear on its
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`face and requires no specialized construction. “Administration” simply means “application” or
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`“to apply” as it relates to pharmaceuticals. In contrast, Apotex retreats from this simplicity, and
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`advances a special definition for “administration” that: (i) finds no support in the intrinsic record;
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`and (ii) is in fact directly at odds with the patents’ prosecution histories. In each instance,
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`Case 1:14-cv-01453-LPS Document 49 Filed 11/30/15 Page 6 of 23 PageID #: 1735
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`Apotex’s intent is transparent: it wants to expand the scope of the claimed invention by
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`impermissibly contravening the intrinsic evidence to drive its litigation strategy.
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`The Court should adopt Plaintiffs’ proposed constructions.
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`I.
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`NATURE AND STAGE OF THE PROCEEDINGS
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`This action under the Hatch-Waxman Act stems from Apotex’s filing of Abbreviated
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`New Drug Application (“ANDA”) No. 207712, which seeks approval to market an unauthorized
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`generic copy of Meda’s Dymista® prior to the expirations of the patents-in-suit. Plaintiff Cipla is
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`the owner of all rights to the patents-in-suit and Plaintiff Meda is the exclusive licensee.
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`This case is in fact discovery, which will close on February 26, 2016. (D.I. 18.) Expert
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`discovery is scheduled to occur from April 1, 2016 through July 15, 2016. (Id.) Trial is scheduled
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`to begin on December 12, 2016. (D.I. 28.) Pursuant to the Court’s scheduling order, the parties
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`exchanged proposed claim terms and proposed constructions, and filed with the Court a Joint
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`Claim Construction Statement for the two terms in dispute. (D.I. 43.)
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`II.
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`SUMMARY OF THE ARGUMENTS
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`1.
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`Plaintiffs’ construction adheres to established Federal Circuit law that patent
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`claims must to be construed as understood by a person of ordinary skill in the art (“POSA”)
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`reading the patents and their prosecution histories. Laryngeal Mask Co. Ltd. v. Ambu A/S, 618
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`F.3d 1367, 1370 (Fed. Cir. 2010). Contravening settled law, Apotex urges this Court to ignore
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`the context of the patents, particularly the specification and prosecution histories, to arrive at
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`unduly broad constructions that make no sense in the context of the intrinsic record.
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`The claim below is representative of the claims in which each disputed term appears:
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`A method for the prophylaxis or treatment in a mammal of a condition for which
`administration of one or more anti-histamines and/or one or more steroids is
`indicated, comprising intranasal administration to said mammal of a
`therapeutically effective amount of a pharmaceutical composition comprising (a)
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`Case 1:14-cv-01453-LPS Document 49 Filed 11/30/15 Page 7 of 23 PageID #: 1736
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`azelastine, or a pharmaceutically acceptable salt thereof; and (b) pharmaceutically
`acceptable ester of fluticasone.
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`’723 patent, claim 1, 11:51-58 (emphases added); see also ’620 patent, claim 16, 12:41-44.
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`2.
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`Plaintiffs maintain that the term “condition(s)” means disease-conditions
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`addressed by the patents-in-suit, i.e., those conditions “resulting in or causing allergic reactions.”
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`That is how a POSA—or even a lay person—would have understood “condition(s)” as it is used
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`in the patents. Indeed, the patents expressly describe the “present invention” as being directed to
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`treatment of “allergic reactions.” ’723 patent, 1:20-22; ’620 patent, 1:11-13. Apotex’s contention
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`that “condition” means any disease or illness, e.g., cancer, irrespective of the patents’ teachings
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`is wrong, and would lead to nonsensical results. All of the disease-conditions referenced in the
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`patents “result in or cause allergic reactions,” a clear indicator that Plaintiffs’ construction is
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`correct and Apotex’s is wrong. Retractable Techs., Inc. v. Beckton, Dickinson & Co., 653 F.3d
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`1296, 1305 (Fed. Cir. 2011) (“In reviewing the intrinsic record to construe the claims, we strive
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`to capture the scope of the actual invention, rather than … allow the claim language to become
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`divorced from what the specification conveys is the invention.”). Ignoring the patents’ context,
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`Apotex seeks to divorce the term “condition” from the inventions claimed in the patents.
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`3.
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`As to “administration,” Plaintiffs maintain that the claim term is clear on its face
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`to a POSA, and requires no departure from the way it is used in the claim language. Neither the
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`claims, specification, nor prosecution history requires, or even suggests, that “administration”
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`means anything different than its plain and ordinary meaning in the pharmaceutical context, e.g.,
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`“application” or “to apply.” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005)
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`(“[T]he words of a claim are generally given their ordinary and customary meaning.”). Not
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`surprisingly, Apotex has not identified any language in the intrinsic record that alters the plain
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`meaning of “administration.” At best, Apotex has identified a passage in the specification where
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`Case 1:14-cv-01453-LPS Document 49 Filed 11/30/15 Page 8 of 23 PageID #: 1737
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`“administration” appears, but this passage does not redefine the term “administration.” Apotex
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`manipulates this passage as a means to improperly expand the scope of the claimed inventions.
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`4.
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`Each claim of the ’723 and ’620 patents is limited to a single dosage form,
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`comprising azelastine and fluticasone as dual active ingredients, suited for simultaneous
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`administration. That is the invention here. Under the guise of construing “administration,”
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`Apotex contends that the invention is “to administer [azelastine and fluticasone] simultaneously,
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`either in the same or different pharmaceutical formulations, or separately or sequentially.” (D.I.
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`43.) Apotex’s construction contradicts the prosecution history, where the patentees deliberately
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`removed language from the claims that Apotex now seeks to reinsert into the claims and advance
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`as its proposed construction.
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`III.
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`STATEMENT OF FACTS
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`A.
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`The Disclosure and Claims of the Patents-in-Suit
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`The ’723 and ’620 patents share a common specification, and issued from the same
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`parent application. The specification expressly describes the claimed invention: “the present
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`invention relates to pharmaceutical products and formulations useful for preventing or
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`minimising [sic] allergic reactions.” ’723 patent, 1:20-22; ’620 patent, 1:11-13 (emphases
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`added). The specification then defines allergic reactions to include allergy-related symptoms,
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`vasomotor-related symptoms, and rhinovirus-related symptoms. ’723 patent, 1:26-28; ’620
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`patent, 1:17-19. These symptoms are similar, though the underlying etiological condition may
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`differ.
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`Allergic rhinitis is a common allergy-related condition addressed by the patents. ’723
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`patent, 1:29-34. Allergic rhinitis is characterized by inflammation of the mucous membrane of
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`the nose, resulting in allergic reactions like nasal congestion, sneezing, nasal itching, and
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`Case 1:14-cv-01453-LPS Document 49 Filed 11/30/15 Page 9 of 23 PageID #: 1738
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`postnasal drainage. Pltfs. Ex. 1 at 31. Historically, allergic rhinitis was treated with, inter alia,
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`oral antihistamines, nasal antihistamines, or nasal corticosteroids. But these conventional options
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`proved unsatisfactory when taken independently or together through separate or sequential
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`administrations; for example, oral antihistamines and nasal steroids offered no benefit over either
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`independent treatment. See, e.g., Joint Claim Construction Chart (“JCCC”) Ex. 20 at ¶¶ 12-13.
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`Duonase (the version of Dymista® sold in India) was the first commercial embodiment
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`of the patents-in-suit. Duonase (like Dymista®) is a breakthrough therapy that represents the first
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`time an antihistamine and corticosteroid were combined in a convenient, single-dosage
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`formulation suitable for simultaneous nasal administration. ’723 patent, 1:43-62; ’620 patent,
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`1:34-53; JCCC Ex. 13 at ¶ 7. Duonase, which is manufactured by Cipla for the Indian market, is
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`a massive commercial success; it has been subject to numerous copycat formulations in that
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`country. See JCCC Ex. 18 at ¶¶8-11. Dymista®, which is the embodiment of the patents-in-suit
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`marketed in the United States, is FDA-approved for the treatment of allergic rhinitis—the first-
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`ever combination-formulation nasal spray approved by the FDA for that purpose.1
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`B.
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`The Prosecution History of the Patents-in-Suit
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`Immediately following its discovery, Cipla filed a patent application in Great Britain on
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`June 14, 2002, and then filed a Patent Cooperation Treaty (“PCT”) application, nationalized in
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`the U.S. as Application No. 10/518,016 (“the ’016 application”), which later issued as the ’620
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`patent. The original claims in the ’016 application initially sought to claim subject matter beyond
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`what ultimately issued as the claims in the ’723 and ’620 patents at issue in this case. For
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`example, the original ’016 application sought to claim: (i) several combinations of anti-histamine
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`1 Reflecting Dymista®’s novelty, FDA did not have approval guidelines in place for such
`a combination formulation, and indeed the FDA was initially unsure how to address Dymista®.
`See generally Pltfs. Ex. 3.
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`Case 1:14-cv-01453-LPS Document 49 Filed 11/30/15 Page 10 of 23 PageID #: 1739
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`and steroid (not just azelastine and fluticasone as here)2; and (ii) separate or sequential use of the
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`two components (and not just simultaneous administration).3
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`During prosecution of the ’620 patent, however, the claims were substantially narrowed.4
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`Of the various changes, the most pertinent for this Markman proceeding is that eleven claims of
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`the as-filed application, and one more new claim added during prosecution, included a
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`“combined preparation for simultaneous, separate or sequential” use limitation. See JCCC Ex. 6
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`at MED_DYM_00000039-43; see also JCCC Ex. 9 at MED_DYM_00000295 (new claim 55).
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`Over time, this limitation was removed, and not one claim ultimately issued with this limitation.
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`See generally ’620 patent, 11:46-14:53.
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`Nine of those initial claims were cancelled, and the patentees removed from the three
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`surviving claims the “simultaneous, separate or sequential” limitation. The patentees (1)
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`highlighted the removal of this limitation, see JCCC Ex. 12 at MED_DYM_00000617, and (2)
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`consistently argued over the examiner’s rejection by emphasizing that the combination (i.e.,
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`simultaneous use) offered significant unexpected benefits over the prior art. See, e.g., JCCC Ex.
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`15 at MED_DYM_00000810-19 (arguing that the prior art was inoperable as a combination and
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`offering objective indicia of non-obviousness of the combination formulation, Duonase).
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`C.
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`The Relevant Person of Ordinary Skill in the Art
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`The hypothetical POSA must have the skill and knowledge related to the subject matter
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`of the patents-in-suit, which relate to both pharmaceutical formulations and compositions
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`2 See JCCC Ex. 6 at MED_DYM_00000037 (original claims 1 and 3).
`3 See JCCC Ex. 6 at MED_DYM_00000039-43 (original claims 26, 28, 30, 33, 35, 37,
`39, 41, 44, 46 and 48).
`4 The claims of ’723 patent were amended during prosecution “to accord with prior art
`identified during prosecution of the parent case 10/518,016.” See JCCC Ex. 2 at
`MED_DYM_00011301.
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`Case 1:14-cv-01453-LPS Document 49 Filed 11/30/15 Page 11 of 23 PageID #: 1740
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`combining azelastine with an ester of fluticasone in the presence of excipients in a single dosage
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`form and also to methods of treating allergic conditions (e.g., allergic rhinitis). Accordingly, the
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`POSA in this case must have the knowledge of both a primary care clinician and a
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`pharmaceutical formulation scientist, or draw from a multi-disciplinary team that knowledge .
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`I.
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`APPLICABLE LAW OF CLAIM CONSTRUCTION
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`ARGUMENT
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`“The words of a claim are generally given their ordinary and customary meaning.”
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`Laryngeal Mask, 618 F.3d at 1370. But they are not interpreted in a vacuum, rather “as
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`understood by a person of ordinary skill in the art in question at the time of the invention when
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`read in the context of the specification and prosecution history.” Id. (emphasis added). The
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`specification is “[u]sually … dispositive; it is the single best guide to the meaning of a disputed
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`term.” Phillips, 415 F.3d at 1315. For example, when the specification “describes the features of
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`the ‘present invention’ as a whole, this description limits the scope of the invention.” Verizon
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`Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1308 (Fed. Cir. 2007).
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`However, the specification “is not a substitute for, nor can it be used to rewrite, the
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`chosen claim language.” SuperGuide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875
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`(Fed. Cir. 2004). “Courts can neither broaden nor narrow claims to give the patentee something
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`different than what he has set forth,” in the claims. Tex. Instruments Inc. v. U.S. Int’l Trade
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`Comm’n, 988 F.2d 1165, 1171 (Fed. Cir. 1993). “The construction that stays true to the claim
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`language and most naturally aligns with the patent’s description of the invention will be, in the
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`end, the correct construction.” Phillips, 415 F.3d at 1316 (internal citation omitted).
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`The prosecution history is also highly relevant to claim construction. Markman v.
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`Westview Instruments, Inc., 52 F.3d 967, 979-80 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370
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`Case 1:14-cv-01453-LPS Document 49 Filed 11/30/15 Page 12 of 23 PageID #: 1741
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`(1996). The prosecution history helps define the claims by “demonstrating how the inventor
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`understood the invention and whether the inventor limited the invention in the course of
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`prosecution, making the claim scope narrower than it would otherwise be.” Trading Techs. Int’l,
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`Inc. v. eSpeed, Inc., 595 F.3d 1340, 1352 (Fed. Cir. 2010) (emphasis added). Thus, the
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`patentee’s statements in prosecution carry significantly more weight than statements not
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`attributable to the patentee, e.g., statements made in prior art references cited during
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`prosecution.5 Finally, during prosecution the patentee may disclaim scope of a term that it might
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`otherwise have had. Chimie v. PPG Industries, Inc., 402 F.3d 1371, 1384 (Fed. Cir. 2005) (“The
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`purpose of consulting the prosecution history in construing a claim is to exclude any
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`interpretation that was disclaimed during prosecution.”).
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`II.
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`PLAINTIFFS’ CONSTRUCTION OF “CONDITION(S)” IS CORRECT
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`The parties’ competing constructions of “condition(s)” are as follows:
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`Term
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`Plaintiffs’ Construction
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`Defendants’ Construction
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`condition(s)
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`disease(s) or illness(es) resulting
`in or causing allergic reaction(s)6
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`Plain and ordinary meaning.
`To the extent that the Court determines
`that this term requires construction,
`Apotex proposes the following
`construction: “disease(s) or illness(es).”
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`
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`5 See Acumed LLC v. Stryker Corp., 483 F.3d 800, 809 (Fed. Cir. 2007) (prior art
`references in the prosecution history are “not created by the patentee in attempting to explain and
`obtain the patent,” so they “merit[] less weight than the evidence of the patentee’s own words.”).
`6 Plaintiffs initially proposed that “condition(s)” means those “condition(s) resulting in or
`causing allergic reaction(s).” (D.I. 43.) In negotiations with Apotex, however, it appears that the
`parties’ dispute centers, not on the meaning of “condition(s)” itself, but rather on which specific
`conditions are encompassed by the patents. Accordingly, Plaintiffs have adopted “disease(s) or
`illness(es)” as part of its construction in an effort to narrow the issues for the Court.
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`Case 1:14-cv-01453-LPS Document 49 Filed 11/30/15 Page 13 of 23 PageID #: 1742
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`A.
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`A POSA Reading the Patents Would Understand “Condition(s)” to Mean
`“condition(s) resulting in or causing allergic reaction(s)”
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`Though claims are given their ordinary and customary meaning, they must be construed
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`“as understood by a [POSA] … when read in the context of the specification and prosecution
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`history.” Laryngeal Mask, 618 F.3d at 1370 (emphasis added). Here, a POSA reading the
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`specification would understand that the disease-conditions that the patents sought to address are
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`“allergy-related” conditions, i.e., “condition(s) resulting in or causing allergic reactions.” See
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`Callicrate v. Wadsworth Mfg., Inc., 427 F.3d 1361, 1366-67 (Fed. Cir. 2005) (“Importantly, the
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`person of ordinary skill in the art is deemed to read the claim term not only in the context of the
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`particular claim in which the disputed term appears, but in the context of the entire patent,
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`including the specification.”) (emphases added). Nowhere does the specification suggest that the
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`inventions apply to any other “disease or illness,” e.g., cancer, as Apotex contends.
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`For example, first and foremost, the specification defines the “present invention”
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`consistent with Plaintiffs’ construction: “the present invention relates to pharmaceutical products
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`and formulations useful for preventing or minimising [sic] allergic reactions.” ’723 patent, 1:20-
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`22; ’620 patent, 1:11-13 (emphases added). The law is settled that an inventor’s description of
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`the “present invention” limits the scope of the invention. See Verizon Servs. Corp., 503 F.3d at
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`1308 (“When a patent thus describes the features of the ‘present invention’ as a whole, this
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`description limits the scope of the invention.”).7 The patent is limited to allergic reactions, or the
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`conditions that cause them, and does not extend to any other “disease or illness.”
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`7 See also AstraZeneca AB v. Hanmi USA, Inc., 554 Fed. App'x 912, 915 (Fed. Cir. 2013)
`(holding phrase “[t]he present invention refers to the new [six named] salts of the single
`enantiomers of omeprazole,” confined the invention to the “six identified cations, disclaiming
`anything else.”); Regents of Univ. of Minn. v. AGA Med. Corp., 717 F.3d 929, 936-39 (Fed. Cir.
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`Case 1:14-cv-01453-LPS Document 49 Filed 11/30/15 Page 14 of 23 PageID #: 1743
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`Second, like the specification, the claims also compel Plaintiffs’ construction. The use of
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`“condition(s)” in the claims is consistent with the specification and Plaintiffs’ construction. A
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`POSA, having read the patent specification and reading each claim in which the term appears,
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`would understand that “condition” is limited to those that “result in or cause an allergic
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`reaction,” not unlimited as encompassing any “disease or illness,” as Apotex contends. The
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`phrase in which “condition(s)” appears in each claim is: “treatment … of condition(s) for which
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`administration of one or more antihistamines and/or one or more steroids is indicated.” See ’723
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`patent, 11:51-58 (claim 1); ’620 patent, 12:41-51 (claims 16, 17), 13:15-23 (claim 24). The
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`specification explains that these two classes of drugs—antihistamines and steroids—are used to
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`treat allergic rhinitis, a common condition that causes allergic reactions. See ’723 patent, 1:29-
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`42; ’620 patent, 1:20-33. The inclusion of these active ingredients provides critical context for
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`the types of conditions encompassed by the claims.
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`Third, other specific claims provide further context and support for Plaintiffs’
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`construction. See Phillips, 415 F.3d at 1314 (“Other claims of the patent in question, both
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`asserted and unasserted, can also be valuable sources of enlightenment as to the meaning of a
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`claim term.”). For example, claims 8 and 9 of the ’723 patent, which depend from claim 1,
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`further narrow “condition” to “allergic rhinitis” and “allergic conjunctivitis.” See ’723 patent,
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`12:5-8. Rhinitis and conjunctivitis are specific examples from the specification of conditions that
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`result in or cause allergic reactions. See ’723 patent, 1:30-34; ’620 patent, 1:21-25. The
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`specification also highlights that azelastine and fluticasone are used as nasal sprays specifically
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`for the treatment of these underlying conditions, see ’723 patent, 1:29-39; ’620 patent, 1:20-30,
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`2013) (holding use of phrase “[t]he present invention provides . . .” disclaimed additional subject
`matter).
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`Case 1:14-cv-01453-LPS Document 49 Filed 11/30/15 Page 15 of 23 PageID #: 1744
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`and it also explains how to ensure that the formulations have the same osmotic pressure as nasal
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`secretions. See ’723 patent 3:27-28, ’620 patent, 3:25-26.
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`By reference to nasal treatment and nasal secretions, the POSA would understand that
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`numerous other claims explicitly or implicitly refer to nasal treatment, such that these claims
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`confirm treatment for allergic symptoms. See, e.g., ’723 patent, 11:64-11:67 (claims 4-5), 12:39-
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`43 (claim 17), 13:1-2 (claim 25); ’620 patent, 12:5-9 (claim 7), 12:13-17 (claim 9); 12:31-40
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`(claims 13-15); 13:15-23 (claim 24), 13:34-42 (claims 28-30); 14:16-17 (claim 39); 14:42-53
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`(claims 47-48). These claims, too, would convey to a POSA that “condition(s)” mean those that
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`result in or cause allergic reactions. The teachings in the specification and claims are dispositive
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`in favor of Plaintiffs’ construction of “condition(s).” Nevertheless, the prosecution history also
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`compels Plaintiffs’ construction. During prosecution, each examiner office action and patentees’
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`response centered on allergic rhinitis subject matter. See generally JCCC Exs. 8, 9, 11, 12, 14,
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`15. There was never a discussion, or even contemplation, that the application pertained to any
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`disease or illness, e.g., cancer, other than those that cause or result in allergic reactions.
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`B.
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`Apotex’s Construction Undermines the Teachings of the Patents and Their
`Prosecution Histories, Which Are Explicitly Directed to Allergic Reactions
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`Apotex’s proposed construction—that “condition(s)” mean any “disease or illness”—is at
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`odds with the clear teachings of the patent specification. Apotex’s construction also is illogical
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`when viewed in light of the specific problem sought to be solved by the claimed inventions—
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`ailments specifically due to allergy-related conditions. See World Class Tech. Corp. v. Ormco
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`Corp., 769 F.3d 1120, 1124 (Fed. Cir. 2014) (rejecting claim construction that ignored the
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`problem solved because “[s]uch a construction is unmoored from, rather than aligned with, the
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`description of the invention.”).
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`Case 1:14-cv-01453-LPS Document 49 Filed 11/30/15 Page 16 of 23 PageID #: 1745
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`While Apotex pays lip service to the “plain and ordinary” meaning of “condition(s),”
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`Apotex nevertheless violates the requirement that applying the plain and ordinary meaning must
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`be “read in the context of the specification and prosecution history.” Laryngeal Mask, 618 F.3d
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`at 1370; see also K-2 Corp. v. Salomon S.A., 191 F.3d 1356, 1365 (Fed. Cir. 1999) (“[C]laim
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`construction is firmly anchored in reality by the understanding of those of ordinary skill in the
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`art.”). And it is the intrinsic evidence—the claims, specification, and prosecution history—that
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`informs a POSA’s understanding. Markman, 52 F.3d at 979-80. Apotex’s construction isolates
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`the term “condition(s),” divorcing it from the intrinsic evidence discussed above.
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`III.
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`PLAINTIFFS’ CONSTRUCTION OF “ADMINISTRATION” IS CORRECT
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`The parties’ competing constructions of “administration” are as follows:
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`Term
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`Pla